Electronic case report forms (eCRFs) are a critical component of the clinical trial data collection process and—when built effectively—can improve data integrity and reduce the potential for error. However, a significant amount of care should be taken when building eCRFs to ensure you’re effectively standardizing data collection and minimizing time spent investigating and correcting problems.
Here we’ve compiled a list of five best practices provided by industry experts to help you effectively build and implement eCRFs for your clinical trials, and see more efficient and higher quality data collection at your research organization.
1. Create an eCRF development standard operating procedure (SOP)
Developing a thorough SOP for designing and building your eCRFs can help ensure standardization across forms, promote consistency across tasks, and ultimately increase productivity for research staff. Good SOPs can also increase the accuracy of data collection by clearly outlining organizational practices and role-specific responsibilities. This specificity helps get all involved staff on the same page, reduces the risk for error in data collection and can make it easier to pinpoint the cause if and when errors occur.
As Anders Lindquist, formerly an Independent Clinical Research Consultant, notes in his article “Data Collection in Clinical Trials: 4 Steps for Creating an SOP,” the best SOPs are often developed collaboratively with multiple staff members at an organization. “It is important to stress that all people involved in doing the tasks and procedures should be involved in the writing and review of the initial SOP development plan. You may want to hold a meeting with staff members to critically evaluate and review tasks” wrote Lindquist.
Involving all relevant staff ensures a better understanding of the tasks involved in data collection and the current practices in place at your organization. It’s also an opportunity to document the best elements of current practices while identifying and course-correcting areas that may deviate from best practices.
2. Mocking-up your form on paper can be helpful
Developing eCRFs requires careful planning and a solid framework to ensure your forms align all individuals and tasks in the data collection process from the very beginning. Creating blueprints for a form before staring the electronic form development allows you to more easily adjust if needed.
In her article “Study and Standard eCRF Creation: Pros of Paper Mock-Up,” Tina Lambert, Data Standards Manager at Astellas Pharma, equates eCRF planning to building a house. “As an architect, you wouldn’t start digging the ground or laying the foundation without first creating an architectural plan so the future owners can get a clear picture of what their home will look like. It wouldn’t be ideal to put in five bathrooms only to learn that the owner decided they actually wanted three” said Lambert.
This metaphor illustrates the importance of creating a mock-up first to save time and avoid making changes during the actual build. Lambert notes it can be helpful to map out a plan on paper before building it electronically in your electronic data capture system (EDC), so you can easily make changes where necessary before the plan is finalized.
3. Ensure the right people are involved in the form design process
As Zeena George, CTMS Business Analyst at Children’s Hospital of Philadelphia notes in her article “Practices for eCRF Design: Defining Roles and Responsibilities,” study coordinators and developers are two key roles that should be involved in the eCRF design and build process. “At the Children’s Hospital of Philadelphia, we have found that it’s critical to determine the roles and responsibilities of those involved with eCRF creation and design” said George.
These two roles must effectively communicate with one another during the form building process and beyond to ensure adequate data is collected during the study. George explains that the study coordinator uses their in-depth knowledge of the protocol and involvement in the study start-up process to inform how data will be collected, what data will be collected, eCRF development timelines and more. The developer then gathers those details to develop the forms (using libraries such as CDE), test the forms, make adjustments before (and after) release, and more.
4. Build forms that collect critical data without over-collecting
It can be tempting to collect as much data as possible during a study, but this can lead to complications and extra work down the road. Tina Schofield, Administrative Director, Children’s Hospital of Philadelphia, explains in her article “Creating Electronic Case Report Forms: Avoid Common Pitfalls” that more is not always better when it comes to data. “If there is too much data collected, it can result in wasted effort by staff and the data can be more difficult to analyze. Keep the focus of the forms on the data that is critical to the study, and hold study teams to what is necessary in the protocol” said Schofield.
It’s important that eCRFs collect the right data to answer your study questions without over-collecting and ultimately making analysis more difficult. When building a form, someone should know the protocol well enough that critical data isn’t missed in eCRF design. This person, likely the study coordinator, should also be able to translate what’s needed from the protocol onto the eCRF or be able to communicate those needs to the developer.
5. Curate a standardized library of forms
Instead of creating new forms for each study, you can maximize data quality, promote consistency across protocols, reduce calendar and form setup timelines for each study and minimize testing burden by creating a library of standardized forms for common data collection needs.
During the 2018 Fall Onsemble Conference, Shannon Roznoski, Director of Product Management at Forte, presented on high-level data collection strategy and detailed form template design examples in her session “Optimizing EDC Form Design for Data Transfer and Data Export.” In her session, Roznoski emphasized the importance of creating a robust CRF design process, including setting data collection standards, involving cross functional teams and building a library of standard forms.
Find the right system to streamline the process
Efficiency in your eCRF development process is often only as good as the systems you choose to implement. When it comes to data management, EDC systems should encourage organizational best practices for data quality rather than deter them. The best EDC systems for form building are easy-to-use and intuitive for all staff members, even for non-developers, and ultimately reduce the potential for error when reporting into the system.
Your EDC system should also be secure, minimize improper data collection and allow you to effectively export your data. Some systems, like Forte EDC, offer features like audits, edit checks, timepoint tolerances, conditional forms and allow for medical coding language to further diminish the potential for improper data entry and increase the integrity of your clinical data. Join us for an open demo on Wednesday, November 6 at 2:00pm Central Time to learn more about how Forte EDC can help streamline and standardize data collection at your organization. Register today to save your seat!